Actively Recruiting
Phase 2 Randomized Multicenter Trial of rF1V-1018 Vaccine Immunogenicity, Safety, and Tolerability in Adults 18 to 55 Years
Led by Dynavax Technologies Corporation · Updated on 2025-10-06
148
Participants Needed
3
Research Sites
20 weeks
Total Duration
On this page
Sponsors
D
Dynavax Technologies Corporation
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the immune response, safety, and tolerability of the rF1V-1018 vaccine in healthy adults aged 18 to 55 years. This phase 2, randomized, multicenter trial focuses on finding the best dose and regimen of the vaccine to protect against pneumonic plague resulting from aerosol exposure to Yersinia pestis. The study is sponsored by Dynavax Technologies Corporation and aims to better understand how the vaccine stimulates the immune system while monitoring for any adverse effects. The trial will test six different dose regimens of the rF1V-1018 vaccine in the first part of the study. Based on those results, up to two regimens will be selected for further evaluation in the second part. Participants will receive the vaccine through injections according to the assigned regimen. The study includes multiple clinic visits for vaccine administration and monitoring. Participants will have blood samples taken at various times to measure immune response to the vaccine. Safety evaluations will occur regularly throughout the trial, including monitoring for injection site reactions and any adverse events for up to six months after the final vaccine dose. The main outcome measures include antibody levels four weeks after the last vaccine and detailed safety assessments. The total participation time varies depending on the dosing schedule and follow-up period.
CONDITIONS
Brief Title
Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 55 years of age
- Healthy or with stable pre-existing medical conditions without major treatment changes in past 3 months
- Able to follow study schedule and procedures
- Able and willing to provide written informed consent
- Women of child-bearing potential must use effective contraception for at least 28 days before vaccination, have negative pregnancy tests before vaccination, and agree to continue contraception for 3 months after final injection
- Women not of child-bearing potential include those with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal ligation
You will not qualify if you...
- History of plague disease or previous plague vaccination
- Active tuberculosis or systemic infection
- History or positive test for HIV, hepatitis B, or hepatitis C
- History of autoimmune disorders
- Sensitivity to any vaccine components
- Body mass index 30 kg/m2 or higher
- Recent receipt of vaccines or investigational agents: within 14 days for inactivated vaccines, within 28 days for live vaccines or investigational drugs
- Recent or planned use of immunosuppressive or immune-modifying drugs within 90 days prior to first vaccine
- Pregnancy, breastfeeding, or planning pregnancy
- Undergoing or expected chemotherapy; recent cancer diagnosis except certain skin cancers
- Any condition or therapy that may interfere with study participation or results
- Fever of 38°C (100.4°F) or higher at vaccination time
- History of acute myocardial infarction or coronary artery disease
Research Team
O
Ouzama Henry, MD, Vice President, Clinical Development
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